Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870397
Status:
RECRUITING
Last Update Posted:
2023-05-23
First Post:
2023-05-04
Brief Title:
Optimal Recheck Time for Helicobacter Pylori Eradication A Prospective Randomized Trial
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Optimal Recheck Time for Helicobacter Pylori Eradication A Prospective Single-center Open-label Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although Urea breath test has been commonly used to recheck the efficiency of Helicobacter pylori eradication there has been no randomized trials comparing the accuracy of Urea breath test results at different times after eradication The investigators aim to assess the accuracy and influence factors of post-therapy test at different times and follow up the cut off samples to optimize the best time to recheck
Detailed Description:
The investigators plan to conduct a single-center open-label randomized controlled study in Zhejiang China Treatment-naive H pylori-positive participants n 900 were randomly assigned to three groups in a 111 ratio with the same eradication regimen amoxicillin 1000 mg clarithromycin 500mg rabeprazole 10mg and colloidal bismuth 200 mg each given twice a day for 14 days Urea breath tests were administered at different times after the treatment 4 to 6 weeks 6 to 8 weeks and 8 to 10 weeks respectively for different groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None